Have you ever heard about Ohio’s Terminal Distributor of Dangerous Drugs (TDDD) licenses? Before last year, the chances are fairly good that you hadn’t. Yet for decades, Ohio state law required pharmaceutical manufacturers to verify that physicians and healthcare organizations either had a TDDD license or were exempt from needing a license before leaving a sample for any prescription drug.
If this is news to you, it was to many others within the industry as well. In fact, even physicians in Ohio were not too familiar with TDDD licenses. However, attention was called to this law early in 2017 when Governor Kasich signed legislation that expanded the list of those required to have a TDDD. The biggest change: All HCPs or HCP practices that purchase or possess controlled substances are required to have TDDD licenses.
In the past, HCPs who practiced as a sole proprietor or who were at a corporate practice with a sole shareholder were exempt. But now, no physician can be exempt when purchasing or possessing controlled substances. However, exemptions are still possible when purchasing or possessing non-controlled substances.
“The expansion of the TDDD licenses was a very unusual case to us, because we were alerted of the new law and its purpose, as Ohio’s way of addressing the opioid crisis, but there was no mention of the [existing] law for drugs that are ‘just Rx,’” explains Teresita Weiss, SVP Regulatory Affairs and Compliance at J. Knipper and Company, Inc., which provides the healthcare industry with solutions in direct marketing, sampling, compliance, information technology, and sales force productivity. “In this case, I don’t think anyone really knew the full scope of this law, because it was in place for some time. And surprisingly enough, as we were doing follow-up calls to identify who actually has a TDDD, we found that many prescribers weren’t even aware of their own state law.”
Uncertainty is never a good thing, especially in an industry as heavily regulated as pharma, so the recent attention brought to Ohio TDDD licenses has left many within pharma feeling uneasy.
“Life sciences manufacturers are very concerned about it, particularly those that sample to healthcare organizations,” says Paul Shawah, Senior Vice President of Commercial Strategy at Veeva, a leader in cloud-based software for the global life sciences industry. “There’s a value in sampling, and it’s often related to getting patients started on a medication faster or helping to reduce the overall cost of providing care. This just adds a layer of complexity to that sampling process and most of our customers are concerned with how they can comply with it.”
Just What Are TDDD Licenses?
Before companies can understand how to comply with these licenses, first they must understand what they are. According to the State of Ohio Board of Pharmacy, which manages the TDDD licenses, “a TDDD is a person (individual, partnership, association, limited liability company, corporation, or government agency) who is engaged in the sale of dangerous drugs at retail, or any person, other than a wholesale distributor or a pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person’s own use and consumption.”
G&M Health, LLC, a health and life-science service company that offers compliance management services to clients that include both Knipper and Veeva as well as more than 100 pharmaceutical companies, had several discussions with the State of Ohio Board of Pharmacy to help clear up any confusion that their clients had about this issue. The company then drafted a white paper to help companies remain compliant with these licenses.
The white paper explains that the Board recognizes the following types of TDDD licenses:
- Category II License: This licensee may possess, have custody or control of, and distribute prescription drugs (including medical oxygen and other medical-grade gases) that are not controlled substances.
- Limited Category II License: This licensee may only possess, have custody or control of, and distribute prescription drugs (including medical-grade gases) that are not controlled substances approved by a Medical Director.
- Category III License: This licensee may possess, have custody or control of, and distribute prescription drugs, including controlled substances contained in Schedules II, III, IV, or V.
- Limited Category III License: This licensee may only possess, have custody or control of, and distribute prescription drugs, including controlled substances approved by a Medical Director.
No exemptions are available for category III licenses. For a category II license, exemptions are available for HCPs who practice as a sole proprietor, are a sole shareholder, or are dentists.
“For example, if I am a physician with my own practice and I function as a single-member LLC, then my practice is exempt,” explains Frank Fazio, a Principal of Porzio, Bromberg & Newman, P.C. and Vice President, Licensing and Distribution Services of Porzio Life Sciences, LLC. “But if you rearrange your LLC, by say, cutting an individual in with a 25% equity in the practice, then it is two-member LLC. Now that practice is no longer exempt. The minute that new individual is brought in, it triggers that obligation to get a TDDD license.”
Additionally, TDDD licenses are also location-based, so the address should match the ordering prescriber’s address. According to G&M Health, “The only instance where the address may not be an exact match is if the prescriber is practicing at a hospital.” In this case, the Board of Pharmacy issues a “campus” license, but there’s a twist: The Board has never issued a “campus” license.
How Can You Remain Compliant with TDDD Licenses
The State of Ohio Board of Pharmacy keeps a list of active licensees that is updated daily and can be downloaded at www.pharmacy.ohio.gov/list. That makes it relatively easy to verify a prescriber’s license, but the required verification process for controlled vs. non-controlled drugs is different.
According to G&M Health’s white paper, prior to distributing samples of a non-controlled drug, a company or sales rep must:
- Verify that the prescriber’s license is in good standing and that there are no restrictions.
- Verify that the TDDD license (if they have one) is active and in good standing.
- If the prescriber is not licensed as a TDDD, then update the company’s sample/complimentary supply request form to:
- State, in a conspicuous manner, the requirements in Ohio law of when a prescriber must hold a TDDD and instructions on where to access the Board’s guidance document on prescriber licensure requirements.
- Require the prescriber who claims an exemption to attest, at least annually, that they meet one of the licensing exemptions.
- Ensure that the attestations are maintained for a period of three years.
However, updating sample/complimentary supply request forms to meet those requirements may be easier than it sounds. For one, pharma companies first have to go through medical/legal/regulatory (MLR) review to have those forms created and approved. But, another issue is just getting everything onto the form.
“Where companies are struggling a little is in putting certain information onto their sample request form,” Fazio explains. “For a lot of companies, it is just about space requirements. A lot of sample request forms are business reply cards, so they’re only so big. And that means you almost have to have a separate card for just Ohio physicians. That also means extra printing expenses. Plus, companies could already have a two-year supply of business reply cards in stock, which they certainly don’t want to just scrap.”
Meanwhile, the requirements for controlled substances are a little simpler:
- Verify that the prescriber’s license is in good standing and that there are no restrictions.
- Obtain a copy of the TDDD’s license or utilize Ohio’s online licensing registry to confirm TDDD licensure.
- Verify the prescriber’s registration with the DEA and verify that the DEA registration and authority to use controlled substances in the course of professional practice has not been restricted by the appropriate professional licensing board or the DEA.
Also, in both cases, when it concerns limited licenses, companies must also confirm that the TDDD’s drug list permits the possession of the specific sample or complimentary supply.
Making the Lives of Sales Reps Easier
Of course, just because a list of physicians with licenses is readily available, doesn’t mean it is easy for reps to constantly check the list for the physicians they are going to meet with. Plus, an added complication—both the HCP the rep is meeting with, and the healthcare organization (HCO) the rep is providing the samples to, must each have the right classification of TDDD license.
“In the most extreme cases, some life sciences companies are just putting all sampling in the state of Ohio on hold,” Shawah says. “But there are workarounds to try to ensure that they’re complying with the regulations, which are very cumbersome and complex.”
For example, Shawah’s company, Veeva, offers new capabilities within Veeva CRM that helps sales reps quickly confirm affiliations between HCPs and HCOs and verify that an organization has an Ohio TDDD license. Furthermore, through licensing data in Veeva OpenData, Veeva CRM will also alert reps if both the HCP and HCO have a license, but one of them doesn’t have the right classification. For instance, if the HCP has a category III license but the HCO only has a category II.
“The challenge is getting that data into the right place at the right time,” Shawah adds. “We’ve tried to make it really easy for the rep so that everything they are doing is still in their normal workflow. It’s the combination of the data and the validation logic all working together at the immediate point of sampling. But, that only solves part of the problem.”
Another problem reps face: The State of Ohio Board of Pharmacy’s list of active licenses does not include a list of HCPs and HCOs that are exempt.
“And that’s really what the issue is: How do you validate that these doctors are exempt?” Fazio says. “It’s easy to validate if they have a license. But it actually becomes more of an issue for the doctors or practices that don’t require it.”
Knipper is another company that offers services to pharma clients’ sales force to help provide them with the data they need when they go on calls. And one way they are addressing the issue of exemptions is through the company’s call center.
“If we become aware of an order in which we’re not able to find a TDDD related to the shipment address, then we will reach out to the prescriber,” Weiss explains. “So, we are trying to assess the exemption by doing follow-up calls, and then we’re recording that as part of our database. Now, of course, the challenge is that prescribers may move to different practices or they may practice at multiple locations. So, figuring that out is a work in progress.”
Companies can also stay up to date on any changing regulations, from Ohio or any other state, through companies like G&M Health.
“We have a product called SHALL, which is an online system our clients have access to that tracks every pending law that affects any pharmaceutical or biotech company,” says Ihab Ghaly, Managing Director at G&M Health. “We also write white papers to tell them what to expect when it becomes law.”
And companies can always expect change.
“What I know for sure is regulations will continue to change,” Shawah adds. “Ohio may change how they do this, or other states may do it slightly differently, all of which creates a bit of a compliance nightmare for life sciences companies. What is important for life sciences companies is that they have the ability to be nimble and keep up with the regulations, and that they also have the capacity to adapt their processes to change and comply.”
And change is coming again. On February 1, 2018, the Board of Pharmacy issued a proposed rule package impacting the pharma industry. The guidance document the Board recently revised is now memorialized in a proposed rule. Will it survive?